Methods and apparatus for a multiple transition temperature implant

ABSTRACT

A shape-memory device manufactured from shape memory material includes multiple activation temperatures. The multiple activation temperatures arise from either the heat treatment of the device during manufacturing, or by combining different elements with different activation temperatures. To manufacture a shape-memory device with multiple activation temperatures, it is formed into a first shape. A first portion of the shape-memory device is heated to a first temperature, and a second portion of the shape-memory device is heated to a second temperature. The shape-memory device is then worked into a second shape. Accordingly, the first portion has a first transition temperature, and the second portion has a second transition temperature. In use, the shape-memory device is placed into a desired position. Energy is applied such that the first portion, second portion, or both portions are transformed.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to implants for the human body and, moreparticularly, but not by way of limitation, to methods and an apparatusfor an implant having multiple transition temperatures.

2. Description of the Related Art

Shape memory alloys such as nitinol have been well known since theirdevelopment in 1965 by Buehler and Wiley (U.S. Pat. No. 3,174,851).Other metals, such as AuCd, FePt.sub.3, beta Brass, and InTI, exhibitshape memory behavior. These materials have the property of changingshape in response to a change in material temperature. This shape changepotential is imparted into the memory metal device through a series ofheat treatments.

The transition temperature range is imparted to the material throughvarying mixtures of intermetallic compounds such as nickel-titanium andheat treatment. The heat treatment methods for the material generallyconsist of a high temperature setting of the desired final shape of adevice followed by a low temperature straining of the device to a secondshape. Then, when the device is in the second shape and brought to thetransition temperature, the device returns to the preprogrammed finalshape. The shape change occurs due to the transition of the materialfrom a martensitic to austenitic phase microstructure. Theseheat-initiated changes cause gross changes in the shape of the implantformed from the memory metal.

Shape memory alloys have been used for a wide range of industrial andmedical applications. Medical applications include but are not limitedto: catheter, intrauterine contraceptive device, gastrointestinalcompression clip, blood vessel filter, coronary artery stent, skinstaple, bone staple, and bone plate. In medical applications, shapememory alloys are generally designed so that they change shape once whenheated to and beyond a specific temperature. The implants and devicesare designed as a whole to transition once from martensite to partial orfull austenite. For example, Fox (U.S. Pat. No. 7,240,677) describes amethod for force, displacement, and rate control of shaped memory metalimplants. Nevertheless, the implants and techniques in this patent donot describe multiple transition temperatures in the same device.

However, in many instances, it may be desirable for an implant or deviceto have either multiple transition temperatures, or multiple elementsthat transition at different temperatures. The existence of multipletransition temperatures would allow, for example, complex devices thatcan be heated first to one shape, and then heated further to additionalshapes. Medical devices in orthopedics could be designed so that theyundergo sequential shape changes for complex treatment of bones. Devicescould also be designed such that part of the device is intentionallyleft in martensite. A device that has a portion that is alwaysmartensitic would be helpful in creating implants that can be deformedto conform to the curvature of bone. Other devices could be designedsuch that there is a shape changing portion that is martensitic at roomtemperature, and a second portion that does not change shape when heatis applied because it is always austenitic at normal temperatures.

Accordingly, a shape memory implant or device that features multipletransition temperatures or multiple elements with different transitiontemperatures would be beneficial to surgeons, as well as personsrequiring bone surgeries, because the shape changing features of thedevice can be more complex and sequentially applied.

SUMMARY OF THE INVENTION

The present invention is a device made from a shape memory material thathas the characteristic of having multiple transition temperatures. Thepresence of multiple transition temperatures allows shape changingdevices to be designed that feature more complex shape changes, or shapechanges that are applied in sequence. The present invention consists ofmethods for heat treating shape memory materials, and methods forattaching materials of different transition temperature characteristics.

The presence of multiple transition temperatures may be accomplished inseveral ways. A shape memory alloy device of may be heat treated suchthat it has multiple transition temperatures, or elements of a shapememory alloy device may include different temperature transitioncharacteristics. These different elements can be shape memory materialsthat are of different elemental composition, or elements that are heattreated differently.

In accordance with the present invention, a shape memory device isformed into a first shape. A first portion of the shape-memory device isheated to a first temperature, and a second portion of the shape memorydevice is heated to a second temperature. The shape-memory device isthen worked into a second shape. Accordingly, the first portion has afirst transition temperature, and the second portion has a secondtransition temperature. In the preferred embodiment, the secondtransition temperature is higher than the first transition temperature.The shape memory device may be formed as a single component, or,alternatively, the first portion and the second portion may be formed asseparate components, whereby the separate components are coupledtogether to create the shape-memory device having multiple transitiontemperatures.

In use, the shape memory device is placed into a desired position. Afirst activation energy is applied to the first portion such that thefirst portion transitions from the second shape to an end use shape.Similarly, a second activation energy is applied to the second portionsuch that the second portion transitions from the second shape to an enduse shape. The end use shape is any shape along the transition from thesecond shape up to and including a first shape.

It is therefore an object of the present invention to provide a shapememory device including multiple transition temperatures.

Still other objects, features, and advantages of the present inventionwill become evident to those of ordinary skill in the art in light ofthe following. Also, it should be understood that the scope of thisinvention is intended to be broad, and any combination of any subset ofthe features, elements, or steps described herein is part of theintended scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A provides a frontal view of a shape-memory device includingmultiple transition temperatures according to a first embodiment.

FIG. 1B provides a perspective view of the shape-memory device includingmultiple transition temperatures according to the first embodiment.

FIG. 2A provides a frontal view of the shape-memory device after a firsttransition temperature has been activated according to the firstembodiment.

FIG. 2B provides a perspective view of the shape-memory device after thefirst transition temperature has been activated according to the firstembodiment.

FIG. 3A provides a frontal view of the shape-memory device after thefirst transition temperature and a second transition temperature havebeen activated according to the first embodiment.

FIG. 3B provides a perspective view of the shape-memory device after thefirst transition temperature and the second transition temperature havebeen activated according to the first embodiment.

FIG. 4A provides a flowchart illustrating the method steps for utilizingthe shape-memory device including multiple transition temperaturesaccording to the first embodiment.

FIG. 4B provides a frontal view of the shape-memory device beforeactivation, and installed into a first and second bone according to thefirst embodiment.

FIG. 4C provides a frontal view of the shape-memory device after a firstportion has been activated according to the first embodiment.

FIG. 4D provides a frontal view of the shape-memory device after asecond portion has been activated according to the first embodiment.

FIG. 5A provides a perspective view of a heat treatment jig according tothe first embodiment.

FIG. 5B provides a flowchart illustrating the method steps formanufacturing the shape-memory device according to the first embodiment.

FIG. 5C provides a perspective view of a shape-memory devicemanufactured from separate components according to an alternative firstembodiment.

FIG. 5D provides a flowchart illustrating the method steps formanufacturing the shape-memory device according to the alternative firstembodiment.

FIG. 6A provides a frontal view of a shape-memory device includingmultiple transition temperatures according to a second embodiment.

FIG. 6B provides a perspective view of the shape-memory device includingmultiple transition temperatures according to the second embodiment.

FIG. 7A provides a frontal view of the shape-memory device after a firsttransition temperature has been activated according to the secondembodiment.

FIG. 7B provides a perspective view of the shape-memory device after thefirst transition temperature has been activated according to the secondembodiment.

FIG. 8A provides a frontal view of the shape-memory device after thefirst transition temperature and a second transition temperature havebeen activated according to the second embodiment.

FIG. 8B provides a perspective view of the shape-memory device after thefirst transition temperature and the second transition temperature havebeen activated according to the second embodiment.

FIG. 8C provides a front view of a shape-memory device having only onetransition temperature according to an extension of the secondembodiment.

FIG. 8D provides a front view of the shape-memory device after the firsttransition temperature has been activated according to the extension ofthe second embodiment.

FIG. 9A provides a frontal view of the shape-memory device in useaccording to the second embodiment.

FIG. 9B provides a frontal view of the shape-memory device after thefirst portion is activated according to the second embodiment.

FIG. 9C provides a frontal view of the shape-memory device after thefirst and second portions have been activated according to the secondembodiment.

FIG. 10A provides a top view of a shape-memory device according to athird embodiment.

FIG. 10B provides a perspective view of the shape-memory deviceaccording to the third embodiment.

FIG. 10C provides an exploded view of the shape-memory device accordingto the third embodiment.

FIG. 10D provides a second perspective view of the shape-memory deviceaccording to the third embodiment.

FIG. 11A provides a top view of the shape-memory device after a firstportion has been activated according to the third embodiment.

FIG. 11B provides a perspective view of the shape-memory device after afirst portion has been activated according to the third embodiment.

FIG. 11C provides a frontal view of the shape-memory device after afirst portion has been activated according to the third embodiment.

FIG. 11D provides a second perspective view of the shape-memory deviceafter a first portion has been activated according to the thirdembodiment.

FIG. 12A provides a top view of the shape-memory device after the firstand second portions has been activated according to the thirdembodiment.

FIG. 12B provides a perspective view of the shape-memory device afterthe first and second portions have been activated according to the thirdembodiment.

FIG. 12C provides a frontal view of the shape-memory device after thefirst and second portions have been activated according to the thirdembodiment.

FIG. 12D provides a second perspective view of the shape-memory deviceafter the first and second portions have been activated according to thethird embodiment.

FIG. 13 provides a flowchart illustrating the method steps ofmanufacturing the shape-memory device according to the third embodiment.

FIG. 14A provides a frontal view of a shape-memory device includingmultiple transition temperatures according to a fourth embodiment.

FIG. 14B provides a perspective view of the shape-memory deviceincluding multiple transition temperatures according to the fourthembodiment.

FIG. 15A provides a frontal view of a shape-memory device includingmultiple transition temperatures after a first portion has beenactivated according to the fourth embodiment.

FIG. 15B provides a perspective view of the shape-memory deviceincluding multiple transition temperatures after the first portion hasbeen activated according to the fourth embodiment.

FIG. 16A provides a frontal view of a shape-memory device includingmultiple transition temperatures after the first and second portionshave been activated according to the fourth embodiment.

FIG. 16B provides a perspective view of the shape-memory deviceincluding multiple transition temperatures after the first and secondportions has been activated according to the fourth embodiment.

FIG. 17A provides a top view of a shape-memory device including a singletransition temperature and a permanently formed section according to afifth embodiment.

FIG. 17B provides a perspective view of the shape-memory deviceincluding the single transition temperature and the permanently formedsection according to the fifth embodiment.

FIG. 17C provides a frontal view of the shape-memory device includingthe single transition temperature and the permanently formed sectionaccording to the fifth embodiment.

FIG. 18A provides a top view of a shape-memory device including thesingle transition temperature and the permanently formed section afterforming the formed section according to the fifth embodiment.

FIG. 18B provides a perspective view of the shape-memory deviceincluding the single transition temperature and the permanently formedsection after forming the formed section according to the fifthembodiment.

FIG. 18C provides a frontal view of the shape-memory device includingthe single transition temperature and the permanently formed sectionafter forming the formed section according to the fifth embodiment.

FIG. 19A provides a top view of a shape-memory device including thesingle transition temperature and the permanently formed section afterforming the formed section and activating a second portion according tothe fifth embodiment.

FIG. 19B provides a perspective view of the shape-memory deviceincluding the single transition temperature and the permanently formedsection after forming the formed section and activating the secondportion according to the fifth embodiment.

FIG. 19C provides a frontal view of the shape-memory device includingthe single transition temperature and the permanently formed sectionafter forming the formed section and activating the second portionaccording to the fifth embodiment.

FIG. 20A provides a flowchart illustrating the method steps formanufacturing the shape-memory device with a first portion having ananatomical conformity, and a second portion having a transitiontemperature according to the fifth embodiment.

FIG. 20B provides a flowchart illustrating the method steps forutilizing the shape-memory device with the first portion having ananatomical conformity, and the second portion having a transitiontemperature according to the fifth embodiment.

FIG. 21A provides a perspective of a shape-memory device including amultiple strand bridge and securing members according to a secondalternative embodiment.

FIG. 21B provides a top view of a shape-memory device including amultiple strand bridge and securing members according to a secondalternative embodiment.

FIG. 21C provides a top view of the shape-memory device having a firstportion activated according to the second alternative embodiment.

FIG. 21D provides a top view of the shape-memory device having a firstand a second portion activated according to the second alternativeembodiment.

FIG. 21E provides a top view of the shape-memory device having a first,second, and third portions activated according to the second alternativeembodiment.

FIG. 21F provides a top view of the shape-memory device having allportions activated according to the second alternative embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which may be embodied in variousforms. It is further to be understood that the figures are notnecessarily to scale, and some features may be exaggerated to showdetails of particular components or steps.

Shape-memory devices may be constructed from virtually any materialexhibiting a shape-memory effect. Examples of shape-memory effectmaterials include, but are not limited to nitinol, AuCd, FePt₃, betaBrass, and InTI. Shape-memory effect materials allow an object to be:formed in an original shape; deformed while in a martensitic state;heated to a point where the deformed object phase changes from themartensitic state to an austenitic state, thereby returning the deformedobject to its original shape; and cooled such that the object retainsthe original shape. Accordingly, the shape-memory devices are formed inan original or first shape, and heat treated to set the original shape.The shape-memory devices, while cold and in the martensitic phase, arethen deformed to a second shape. Next, the shape-memory devices areheated to a prescribed transition temperature until they phase change toan austenitic phase, thereby returning from the deformed or second shapeto the original or first shape. Finally, the shape-memory devices coolwhereby the shape-memory devices retain the original first shape.

In this invention, shape-memory devices with a single transitiontemperature are expanded to include shape-memory devices with multipletransition temperatures. The move to multiple transition temperaturesrequires the recognition that a shape-memory device of a homogeneousmaterial may be manipulated through varied heat treatment processes,thereby creating portions on the homogeneous material that reactdifferently upon the application of activation energy. Alternatively, ashape memory device may be constructed from multiple components, whereineach component includes a respective transition temperature, therebyproviding the shape memory device with multiple transition temperatures.

As shown in FIGS. 1A through 3B, a shape-memory device 100 includes afirst portion 101 having a first transition temperature and a secondportion 102 having a second transition temperature. In this example, theshape-memory device 100 is a staple that may be utilized as an implant,and includes a bridge 106, a first leg 107, and a second leg 108. Thefirst and second legs 107-108 are disposed on opposite ends of thebridge 106. The first leg 107 includes an upper segment 110 and a lowersegment 111, and the second leg 108 includes an upper segment 112 and alower segment 113. The lower segments 111 and 113 include an end thatcontracts inward when activation energy is applied. Also in thisembodiment, the bridge 106 contracts upon the application of activationenergy, thereby drawing the legs 107-108 closer.

The first portion 101 includes the lower segments 111 and 113 of thelegs 107-108, including the ends that contract inward upon theapplication of energy. The first portion 101 further includes a firstshape 127 and a second shape 128, whereby the ends of the first andsecond legs move inward when the temperature of the first portion 101elevates toward the first activation temperature.

The second portion 102 includes the bridge 106 and the upper segments110 and 112 of the legs 107-108. The second portion 102 also includes afirst shape 137 and a second shape 138, whereby the bridge 106 commencesto contract when the temperature of the second portion 102 nears thesecond activation temperature, and is in the first shape 137 when thesecond portion 102 reaches the second transition temperature. While thisembodiment has been shown with the first portion 101 and the secondportion 102 interfacing at a central portion of the legs 107-108, one ofordinary skill in the art will recognize that virtually any point may beutilized as a boundary between the first portion 101 and the secondportion 102, dependent upon fixture designs, component designs, heattreatment jig designs, and the like.

While this embodiment has been shown with the shape-memory device 100having two portions 101 and 102 moving from the second shapes 128 and138 to the first shape 127 and 137, respectively, it should be apparentthat both portions 101 and 102 are usable at virtually any point alongthe transition between the second shapes 128 and 138 and the firstshapes 127 and 137, respectively. Accordingly, an end-use shape maydesignate any shape between the second shapes 128 and 138, up to andincluding the first shapes 127 and 137, respectively. The amount of heatenergy applied to the deformed shape determines the amount of transitionfrom the second shapes 128 and 138 to the first shapes 127 and 137,respectively.

While the shape memory device 100 has been shown with a first portion101 activating before the second portion 102, one of ordinary skill inthe art will recognize that the second portion 102 may be activatedbefore the first portion 101, if so desired. Accordingly, the bridge 106may contract before the legs 107-108. Further, a shape memory deviceincluding more than two portions may activate the portions insubstantially any order to achieve varied results.

As shown in FIG. 1A, both the first portion 101 and the second portion102 of the shape-memory device 100 are disposed in the second shapes 128and 138, at temperatures below the commencement point for Austenite toform (A_(s)). FIG. 2A provides an illustration of the shape-memorydevice 100 after heat energy at the first transition temperature hasbeen applied to the first portion 101. In this configuration, the heatenergy has been delivered to the first portion 101, thereby raising thetemperature of the first portion 101 of the shape-memory device 100 tothe point where the entire first portion 101 is Austenite (A_(F)-FirstPortion). At temperature A_(F)-First Portion, the first portion 101 hasfully transitioned to the first shape 127, wherein the ends of the legs107 and 108 contract inward. As shown in FIG. 2A, the second portion 102remains in the second shape 138, because the transition temperature forthe second portion 102 is higher than the transition temperature for thefirst portion 101.

Upon the continued application of heat energy to the shape-memory device100 above the A_(s)-Second Portion temperature, the second portion 102commences to shape change, and continues to shape change until theA_(F)-Second Portion temperature is reached, at which point the bridge106 has fully contracted to the first shape 137, as shown in FIGS.3A-3B.

FIG. 4A provides a flowchart illustrating the method steps for utilizingthe shape-memory device 100 having multiple activation temperatures. Theprocess commences with the placement of the shape-memory device 100 intoa desired position, step 10. The operator must then deliver a firstactivation energy to raise the temperature of a first portion 101 to atleast temperature A_(F)-First Portion, thereby forcing the first portion101 of the shape-memory device 100 to move from the second shape 128 tothe first shape 127, step 12. The operator then delivers a secondactivation energy to the second portion 102 of the shape-memory device100 to reach A_(F)-Second Portion, at which point the second portion 102has shape changed from the second shape 138 to the first shape 137, step14. At that point, both transition temperatures have been reached.

In cases where the shape-memory device 100 is implanted into a livebody, the first and second transition temperatures may be below nominalbody temperatures, above nominal body temperatures, or a combination ofboth. One of ordinary skill in the art will recognize that virtually allcombinations may be utilized in a living body for varied results,including partial alignment of bones, fine alignment of bones, securingto bones, aids in bone fusion, and the like. Illustratively, an implantas shown in FIGS. 1A through 3B may have characteristics wherein thefirst portion 101 transition temperature is below the nominal bodytemperature, and the transition temperature of the second portion 102 isabove the nominal body temperature. In this case, the first portion 101would commence to shape change upon the insertion of the implant intothe living body, and the second portion 102 would be activated to drawattached objects together. Upon heating of the implant to nominal bodytemperature, the first portion 101 shape changes to the first shape 127,thereby further securing the implant to attached structure, includingbones or other restraint components.

One of ordinary skill in the art will recognize that each of theportions 101 or 102 of the shape-memory device 100 may be activatedindependently, together, or only one transition may be deemed necessary,dependent upon site-specific conditions, or desires of the operator.

The method steps for utilizing a shape-memory device 100 under in vivoconditions follows the method flowchart shown in FIG. 4A. As shown instep 10, a surgeon places the shape-memory device 100 having multipletransition temperatures into the body. As shown in FIG. 4B, the legs107-108 of the shape-memory device 100 are installed into a first bone130 and a second bone 131. The surgeon then utilizes any suitablenecessary transition device to initiate a first desired transformationof a first portion 101 of the implant, as shown in FIG. 4C. One ofordinary skill in the art will recognize that multiple forms of heatenergy are commonly available, including body heat, heating probes, andmay be utilized at varying points to achieve desired results.Illustratively, the surgeon may utilize body heat to deliver energy tothe first portion, and may utilize heating probes as the activationenergy for a second portion 102. In this specific example, the ends ofthe legs 107-108 are activated first, thereby securing the shape-memorydevice 100 to the bones 130-131. Step 14 provides for utilizing anecessary transition device to initiate the second desiredtransformation, thereby shape-changing the second portion 102 of theimplant toward the respective first shape 137, as shown in FIG. 4D.

In the manufacturing process, the shape-memory device 100 is formed in adesired first shape and heat treated in a heat treatment jig 120 havinga first platen 121 and a second platen 122. The first platen 121 isdisposed adjacent to the first portion 101 of the shape-memory device100, and the second platen 122 is disposed adjacent to the secondportion 102 of the shape-memory device 100. In this specific example,the first platen 121 is constructed from a different material than thesecond platen 122, and therefore has different thermal conductivityproperties. Accordingly, the first portion 101 and the second portion102 receive different heat treatments from the first platen 121 and thesecond platen 122.

Alternatively, the first platen 121 and the second platen 122 may beformed from like materials, wherein at least one is altered to limitthermal conduction to a mating shape-memory device 100. Illustratively,a first platen 121 may include a fluid passage 123 for flowing a fluidto cool the first platen 121. In such a case, the cooled platen would beat a different temperature than the unaltered platen, thereby forcingthe first and second platens 121-122 to deliver varied heat treatmentsto the shape-memory device 100 disposed within the heat treatment jig120. One of ordinary skill in the art will recognize that the heattreatment of a component may also be affected by the duration of theheat treatment.

FIG. 5B provides a method flowchart illustrating′ the method steps forcreating a shape-memory device 100 having multiple transitiontemperatures. The process commences with creating a shape-memory device100 that is formed into a desired first shape 127 and 137, step 26. Step28 provides for creating a heat treating jig 120 including platens121-122 having varied thermal conduction properties, either naturally orartificially induced, wherein the less conductive material is disposedaround the portions of the shape-memory device 100 with a lower desiredtransformation temperature. Step 30 provides for placing theshape-memory device 100 into the jig 120 and heat treating theshape-memory device 100. In step 32, the shape-memory device 100 isremoved from the jig 120 and worked into the desired second shapes 128and 138, respectively.

Alternatively, a shape-memory device 150 similar in shape and functionto the shape-memory device 100 may be formed utilizing multiplecomponents, wherein the shape-memory device 150 moves from a secondshape to a first shape upon the application of activation energy. Asshown in FIG. 5C, the shape-memory device 150 includes a bridge 156, afirst leg 157, and a second leg 158. The first leg 157 includes an uppersegment 164 and a separate lower segment 163 that includes an end thatcontracts inward when activation energy is applied, and the second leg158 includes an upper segment 162 and a separate lower segment 161 thatincludes an end that contracts inward when activation energy is applied.The shape-memory device 150 further includes a first portion 151 and asecond portion 152 that have different transition temperatures.

In this alternative embodiment, the interface between the first portion151 and the second portion 152 similarly passes through a mid portion ofthe first and second legs 157-158. A free end of the upper segment 164includes a recess 169, and a free end of the upper segment 162 includesa recess 170. The lower segment 163 includes a first protrusion 167 andthe lower segment 161 includes a second protrusion 168. The firstportion 151 includes the lower segments 163 and 161, and the secondportion 152 includes the bridge 156 and the upper segments 162 and 164.

In this alternative embodiment, the lower segments 161 and 163 areformed at a first transition temperature and the bridge 156 and uppersegments 162 and 164 are formed at a second transition temperature. Thelower segments 161 and 163 are then assembled together with the uppersegments 162 and the bridge 156 to create the composite shape-memorydevice 150. In this specific example, the protrusions 167-168 arecomplementary in shape to the recesses 169-170, and of a size suitablefor being press fit into a respective recess 169 or 170. Illustratively,the first protrusion 167 is press fit into the recess 169, and thesecond protrusion 168 is press fit into the recess 170, such that thecontracting ends contract toward each other when moving from the secondshape to the first shape, in similar fashion to the first embodiment.

FIG. 5D provides a flowchart illustrating the method steps formanufacturing the shape-memory device 150 according to this invention.The manufacturing process commences with step 36, wherein a shape-memorydevice is split into multiple components, each having a desiredactivation temperature. Each component is formed in the respective firstshape. The process continues with step 38, wherein a heat treatment jigis created for each component. Step 40 provides for separatelyheat-treating each component to achieve the desired transformationtemperature. Next, the components are removed from the heat-treatingjigs and assembled together using any suitable process, step 42. In thisspecific example, the different components are press fit together,however, one of ordinary skill in the art will recognize that virtuallyany form of attachment may be utilized, provided that adequaterestraining forces are achieved. The shape-memory device 150 is thenworked into the respective second shapes, step 44.

As the assembled shape-memory device 150 is now a single unit, use ofthe shape-memory device 150 is substantially identical to theshape-memory device 100. Accordingly, the methods provided in FIGS.4A-4D are applicable to the shape-memory device 150, and will thereforenot be further described.

While this specific example has been shown with separate componentsbeing press fit together, one of ordinary skill in the art willrecognize that virtually any form of mechanical attaching scheme may beutilized if it provides adequate results, including welding, mechanicalfasteners, and the like. One of ordinary skill in the art will furtherrecognize that the changing of the interface between the first portion151 and the second portion 152 to a plane parallel to the cross sectionis for design and manufacturing simplification purposes.

In a second embodiment, a shape-memory device 200 includes a firstportion 201 having multiple zones, and a second portion 202 having asingle zone. As shown in FIG. 6A, the first portion 201 includes a firstzone 204 and a second zone 205 that have a first shape 227 and a secondshape 228, and a first transition temperature. The second shape 228 isshown in FIGS. 6A-6B while the first shape 227 is shown in FIGS. 7A-7B.The second portion 202 includes a second shape 238, shown in FIGS.7A-7B, and a first shape 237, shown in FIGS. 8A-8B, and a secondtransition temperature. In this example, the shape-memory device 200 isa staple that may be utilized as a surgical implant, and includes afirst leg 207, a second leg 208, a bridge 206, a first bend 210, and asecond bend 211.

In this second embodiment, the first bend 210 is disposed between thefirst leg 207 and the bridge 206, and the second bend 211 is disposedbetween the second leg 208 and the bridge 206. The first bend 210 andthe second bend 211 contract inward upon the application of activationenergy, such that the ends of the legs 207-208 are closer together inthe first shape 227.

The first zone 204 of the first portion 201 encompasses the first leg207 and the first bend 210, and the second zone 205 of the first portion201 encompasses the second leg 208 and the second bend 211. As the firstzone 204 and the second zone 205 of the first portion 201 have the sametransition temperature, the first bend 210 and the second bend 211transition from the second shape 228 to the first shape 227substantially symmetrically, and at the same time, as shown in FIGS.7A-7B. In this specific example, the bends 210-211 contract inwardapproximately thirty degrees. While this example has been shown with acontraction of approximately thirty degrees, one of ordinary skill inthe art will recognize that virtually any angle of contraction may beutilized, dependent upon the limits of shape-memory materials.

The second portion 202 encompasses the bridge 206, and is disposedbetween the first and second bends 210-211. In this second embodiment,the bridge 206 includes a transition member 239. As shown in FIGS.8A-8B, the bridge 206 includes a first member 240, a second member 241,and the transition member 239 disposed between the first and secondmembers 240-241. In this specific example, the transition member 239 isa bend having a midpoint. The first member 240 is connected to the firstbend 210, and the second member 241 is connected to the second bend 211.In the second shape 238, the transition member 239 spans approximatelyone hundred and eighty degrees, thereby placing the first and secondmembers 240-241 substantially collinear. Upon the application ofactivation energy, the transition member 239 contracts inward, therebymoving the ends of the legs 207-208 closer. In the first shape 237, thetransition member 239 is disposed at approximately thirty degrees,however, one of ordinary skill in the art will recognize that virtuallyany bend angle may be utilized, dependent upon the limitation ofshape-memory materials, and shape-memory device designs.

In use, the shape-memory device 200 substantially follows the methodflowchart provided in FIG. 4A, wherein the shape-memory device 200 isplaced into a desired working position. In this example, the desiredworking position is shown in FIG. 9A, and provides for the first leg 207of the shape-memory device 200 to be installed onto a first bone 220 andan adjacent second bone 221. With both portions 201 and 202 in theirrespective second shapes 228 and 238, the first leg 220 is inserted intothe first bone 220, and the second leg 208 inserted into the second bone221. As shown in step 12 of FIG. 4A, the surgeon initiates a firstdesired shape transformation by delivering activation energy to thefirst and second zones 204-205 of the first portion 201, thereby forcingthe transformation of the first and second bends 210-211 from the secondshape 228 to the first shape 227 and drawing the first and second bones220-221 toward each other, as shown in FIG. 9B. Alternatively, body heatmay be utilized as activation energy for the first portion 201. Thesurgeon then moves to step 14, wherein the surgeon initiates a seconddesired shape transformation by applying activation energy to the secondportion 202. Upon the application of activation energy to the secondportion 202, the transition member 239 contracts, thereby rotating thesecond bone 221 relative to the first bone 220, as shown in FIG. 9C.Alternatively, if body heat is not utilized as activation energy for thefirst portion 201, body heat may be utilized as activation energy forthe second portion 202. Illustratively, in this example, the second bone221 rotates approximately thirty degrees relative to the first bone 220to reach the first shape 237 of the second portion 202. One of ordinaryskill in the art will recognize that the second portion 202 may becontracted to any angle up to and including the thirty degrees shown.

In an extension of the second embodiment, the shape-memory device 200shown as a multiple activation temperature shape-memory device may alsobe formed as a single transition temperature shape-memory device 250. Inthis alternative embodiment, the structure of the shape-memory device250 is substantially identical to the shape-memory device 200, andtherefore has been labeled with like numerals. As shown in FIGS. 8C and8D, the shape-memory device 250 includes only a single portion, andtherefore has only one transition temperature.

In a first shape 257, the first and second members 240-241 of the bridge206 are disposed at an angle of approximately thirty degrees, and thelegs 207-208 are disposed at an angle of approximately sixty degreesfrom a connecting first or second member 240 or 241. While thisextension of the second embodiment has been shown with the legs 207-208and the first and second members 240-241 disposed at approximately sixtydegrees from the bridge 206 components, one of ordinary skill in the artwill recognize that virtually any bend angle and bend direction may beutilized, dependent upon the limitation of shape-memory materials, andshape-memory device designs.

In a second shape 258, the first and second legs 207-208 are disposedsubstantially perpendicular to the bridge 206 components, and the firstand second members 240-241 are substantially planar. As shown in FIG.8C, the bridge 206 is substantially parallel to a horizontal axis 251and the legs 207-208 are substantially parallel to a vertical axis 252.One of ordinary skill in the art will recognize that virtually any bendangle may be utilized for a second shape, dependent upon the limitationof shape-memory materials, and shape-memory device designs.

Upon the application of activation energy, all shape-changing componentsof the shape-memory device 250 transition from the second shape 258 tothe first shape 257 substantially simultaneously. Use of theshape-memory device 250 is similar to the shape-memory device 200,wherein the legs 207-208 restrain the shape-changing bridge 206 to firstand second bones, and the bridge 206 reorients the first and secondbones when the bridge 206 shape-changes.

The transition from the second shape 258 to the first shape 257 occurswith recognizable force. As shown in FIG. 8D, a force is created betweenthe legs 207-208 when the bends 210-211 contract. Additionally, a forceis created between the legs 207-208 when the transition member 239contracts, as an effective bridge length decreases when moving from thesecond shape 258 to the first shape 257. Illustratively, a bridge length243 for the second shape 258 is longer than a bridge length 242 for thefirst shape 257, thereby creating compressive forces between the legs207-208 as the bridge 206 contracts.

While this embodiment has been shown with the transition member 239 as abend, one of ordinary skill in the art will recognize that virtually anyform of transition member may be utilized to provide varied results. Oneof ordinary skill in the art will further recognize that the transitionmember 239 and the bends 210-211 may contract or expand dependent upondesired results.

In a third embodiment, a shape-memory device 300 is formed utilizinglayers. As shown in FIGS. 10A-10D, the shape-memory device 300 includesa first portion 301 having a first transition temperature, a first shape327, and a second shape 328, and a second portion 302 having a secondtransition temperature, a first shape 337, and a second shape 338. Inthis third embodiment, the portions 301 and 302 are disposed in layers.The first shape 327 is shown in FIG. 11C-11C, and the first shape 337 isshown in FIG. 12A.

The first portion 301 includes a bridge 306, first through fourth legs307-310, and first through fourth bends 312-315. In this specificexample, the bridge 306 is planar and includes a mounting surface 318and an aperture 317. The first and third legs 307 and 309 are disposedon a single end of the bridge 306, and the second and fourth legs 308and 310 are symmetrically disposed on an opposite end of the bridge 306.The first through fourth bends 312-315 are disposed between the firstthrough fourth legs 307-310, respectively, and the bridge 306, as shownin FIG. 10B.

In the second shape 328, the legs 307-310 are disposed substantiallyperpendicular to the bridge 306, such that the bends 312-315 spanapproximately ninety degrees. Upon the application of heat energy to thefirst portion 301, the bends 312-315 contract approximately thirtydegrees, such that the legs 307-310 are disposed at approximately sixtydegrees relative to the bridge 306 in the first shape 327, as shown inFIGS. 11A-11D.

The second portion 302 includes a plate 320 having a contractionfeature, and is of a size complementary to the bridge 306 of the firstportion 301. In this specific example the contraction feature is acollapsing aperture 321. A mating surface 323 of the plate 320 isdisposed on the mounting surface 318 of the bridge 306, such that thecollapsing aperture 321 is in alignment with the aperture 317 of thebridge 306. The plate 320 may be secured to the bridge 306 utilizing anysuitable means known in the art, including welding, press-fitting,adhesives, and the like. While the contraction feature of this examplehas been shown as a collapsing aperture 321, one of ordinary skill inthe art will recognize that virtually any form of contraction orexpansion feature may be utilized to deliver forcible displacement.

In the second shape 338, the plate 320 is planar and the collapsingaperture 321 is at a full-round position. In the first shape 337, plate320 maintains the planar form, however, the collapsing aperture 321collapses through the aperture, thereby drawing a first end 330 and asecond end 331 of the plate 320 closer. In this specific example, thecontraction feature collapses to an X-Y plane, as shown in FIG. 12D.While this embodiment has been shown with the collapsing aperture 321collapsing through the plane X-Y, one of ordinary skill in the art willrecognize the virtually any plane may be selected as a collapse plane,dependent upon desired contractions.

Upon appropriate attachment of the plate 320 to the bridge 306, theshape-memory device 300 has multiple portions having differenttransition temperatures, as disclosed in the previous embodiments, andtherefore follows the method flowchart of FIG. 4A. As shown in step 10,the shape-memory device 300, in the second shapes 328 and 338, is placedinto a desired working position. Once installed, the user may initiate afirst desired transformation, step 12. In this specific example, theuser provides activation energy to the first portion 301, to move thefirst portion 301 from the second shape 328 to the first shape 327,thereby contracting the bends 312-315 and bringing the ends of the legs307-310 closer together. Step 14 provides for initiating a seconddesired transformation of a second transition temperature. As shown inFIGS. 12A-12D, the user delivers activation energy to the second portion302 to move the plate 320 from the second shape 338 to the first shape337, thereby contracting the collapsing aperture 321, and providingcompressive forces between the first and third legs 307 and 309, andbetween the second and fourth legs 308 and 310.

Manufacturing of the shape-memory device 300 that includes multiplelayers for independent activation requires the separate formation ofeach layer in the respective first shape, independent heat treatment tocreate a shape-memory profile, and bonding of the layers together.Illustratively, in this third embodiment the first portion 301 and thesecond portion 302 are welded together along the outer edges. Aspreviously disclosed, each layer includes a first shape and a secondshape, and may be worked from the first shapes to second shapes, therebycreating the ability to move from the second shape to the first shapeupon the application of activation energy. While this shape-memorydevice 300 has been shown with the first portion 301 and the secondportion 302 welded together, one of ordinary skill in the art willrecognize that any form of suitable connection may be utilized to bondthe layers to one another, including mechanical fasteners, adhesivebonds, and the like.

As shown in the method flowchart of FIG. 13, the process formanufacturing the shape-memory device commences with step 50, whereinthe shape-memory device 300 is formed into the first portion 301 thatdelivers a first desired transformation action and the second portion302 that delivers a second desired transformation action. In thisspecific example of the manufacturing process, the first portion 301 isformed in the first shape 327, and the second portion 302 is formed inthe first shape 337. The process then requires the creation of a heattreatment jig for each layer, step 52. Step 54 provides for heattreating each layer separately based on the desired transformationtemperature. As previously disclosed, heat treatment processes may bealtered through both duration and temperature of the heat treatment.Upon completion of the heat treatments, the layers are removed from thejigs, stacked and bonded together to create the shape-memory device 300in the first shapes 327 and 337, step 56. After bonding, the first andsecond portions 301 and 302 of the shape-memory device 300 are workedinto the second shapes 328 and 338, step 58. As such, activation energymay be delivered to first portion 301 or the second portion 302 to causea desired transformation action.

While this embodiment has been shown with two distinct layers, one ofordinary skill in the art will readily recognize that virtually anynumber of layers may be utilized. One of ordinary skill in the art willfurther recognize that the use of individual layers having differenttransition temperatures does not preclude the use of layers havingmultiple transition temperatures as described in the previousembodiments.

In a fourth embodiment, a shape-memory device 400 includes a firstportion 401 having a first transition temperature, and a second portion402 having a second transition temperature. In this example, theshape-memory device 400 is a pin, and includes a body 404 having a firstend 406, a second end 407, and a flange 405. As shown in FIGS. 14A-14B,the first portion 401 and the second portion 402 meet substantially at amidpoint of the shape-memory device 400.

The first portion 401 encompasses the first end 406, and includes afirst shape 427 and a second shape 428. The first end 406 includes afirst through fourth prongs 411-414. In the second shape 428 the firstthrough fourth prongs 411-414 are adjacent to each other, such that thefirst end 406 is pointed. In the first shape 427, shown in FIG. 15A-15B,the first through fourth prongs 411-414 are disposed at an anglerelative to the body 404. Illustratively, in this fourth embodiment, theprongs 411-414 are disposed at an angle of approximately thirty degreesrelative to the axis of the cylindrical body 404.

The second portion 402 encompasses the second end 407 and the flange405, and includes a first shape 437 and a second shape 438. In thesecond shape 438 the flange 405 includes a planar face 415. The planarface 415 is disposed on the second end 407 of the body 404. In the firstshape 437, shown in FIG. 16A-16B, the planar face 415 extends toward thefirst end 406, substantially parallel to the axis of the cylindricalbody 404, thereby shortening the distance between the planar face 415and the first through fourth prongs 411-414.

While this embodiment has been shown with the shape-memory device 400having two portions 401 and 402 moving from the second shapes 428 and438 to the first shapes 427 and 437, respectively, it should be apparentthat both portions 401 and 402 are usable at virtually any point alongthe transition between the second shapes 428 and 438 and the firstshapes 427 and 437, respectively. Accordingly, an end-use shape maydesignate any shape between the second shapes 428 and 438 and up to andincluding the first shapes 427 and 437, respectively. The amount of heatenergy applied to the deformed shape determines the amount of transitionfrom the second shapes 428 and 438 to the first shapes 427 and 437,respectively.

As shown in FIG. 14A, both the first portion 401 and the second portion402 of the shape-memory device 400 are disposed in the second shapes 428and 438, at temperatures below the commencement point for Austenite toform (A_(s)). FIG. 15A provides an illustration of the shape-memorydevice 400 after heat energy has been applied to the first portion 401.At this point, the temperature of the first portion 401 has been raised,and the entire first portion 401 has been converted to Austenite attemperature A_(F)-First Portion. Accordingly, the first portion 401 hasfully transitioned to the first shape 427, wherein the prongs 411-414extend outward. As shown in FIG. 15A, the second portion 402 remains inthe second shape 438, because the transition temperature for the secondportion 402 is higher than the transition temperature for the firstportion 401.

Upon the continued application of heat energy to the shape-memory device400 to the A_(s)-Second Portion temperature, the second portion 402commences to shape change, and continues to shape change until theA_(F)-Second Portion temperature is reached, at which point the flange405 has fully contracted to the first shape 437, as shown in FIGS.16A-16B.

Use of the shape-memory device 400 having multiple activationtemperatures follows the flowchart illustrated in FIG. 4A. The processcommences with the placement of the shape-memory device 400 into adesired position, step 10. Illustratively, the shape-memory device 400may be placed into a hole. The operator must then deliver activationenergy to raise the temperature of a first portion 401 to at leasttemperature A_(F)-First Portion, thereby forcing the first portion 401of the shape-memory device 400 to move from the second shape 428 to thefirst shape 427, step 12. In this specific example, the prongs 411-414extend outward, thereby securing the shape-memory device 400 in thehole. The operator then delivers adequate heat energy to the secondportion 402 of the shape-memory device 400 to reach A_(F)-SecondPortion, at which point the second portion 402 has shape changed fromthe second shape 438 to the first shape 437, step 14. In this example,the flange 405 extends toward the first end 406 in a directionsubstantially parallel to the axis of the cylindrical body 404. At thatpoint, both transition temperatures have been reached.

The shape-memory device 400 may be utilized as an implant in a livingbody in similar fashion to the first embodiment, and therefore followsthe flowchart of FIG. 4A. As described in the flowchart of FIG. 4A, asurgeon has the flexibility to initiate the desired transformations invirtually any order, dependent upon site specific conditions and desiredresults. Accordingly, the surgeon may repeatedly deliver activationenergy to a first or second portion 401 or 402 to effect a desiredchange.

In an alternative embodiment, a shape-memory device 500 includes a firstportion 501 having no transition temperature, and a second portion 502having a transition temperature, as shown in FIGS. 17A-17C. The firstportion 501 may be formed from a shape-memory material that is at a pureAustenite state or a pure Martensite state.

In this specific example of the shape-memory device 500 the secondportion 502 includes multiple zones, a first shape 537 shown in FIG.19C, and a second shape 538, shown in FIG. 17A-B. Illustratively, theshape-memory device 500 is a staple that includes a bridge 506, firstthrough fourth legs 507-510, and first through fourth bends 512-515. Thefirst and third legs 507 and 509 are disposed on a same side of thebridge 506, and the second and fourth legs 508 and 510 are symmetricallydisposed on an opposite end. In this example, the first bend 512 isdisposed between the first leg 507 and the bridge 506, the second bend513 is disposed between the second leg 508 and the bridge 506, the thirdbend 514 is disposed between the third leg 509 and the bridge 506, andthe fourth bend 515 is disposed between the fourth leg 510 and thebridge 506.

The bridge 506 is disposed within the first portion 501. The bridge 506is planar in shape, and does not move from a second shape to the firstshape. However, the bridge 506 may be formed to adapt to anatomicalconditions. As shown in FIGS. 18A-18C, the bridge 506 is formed in a“wave” shape to conform to multiple bones. One of ordinary skill in theart will recognize that virtually any shape form may be utilized toadapt to various anatomical conditions. Illustratively, the bridge 506may be formed at any angle, any curved shape, channels sections, and thelike.

The second portion encompasses the first through fourth legs 507-510 andthe first through fourth bends 512-515, as shown in FIGS. 19A-19C. Inthe second shape 538, the bends 512-515 span substantially ninetydegrees, such that the legs 507-515 are substantially perpendicular tothe bridge 506. In the first shape 537, the bends 512-515 spanapproximately sixty degrees. The ends of the first and second legs507-508 move toward each other as the second portion 502 moves from thesecond shape 538 to the first shape 537. Substantially simultaneously,the ends of the third and fourth legs 509-510 move toward each other asthe second portion 502 moves from the second shape 538 to the firstshape 537. Accordingly, contraction forces are created between the legsof the different zones 504-505 of the second portion 502. In thisspecific example, direct contraction forces are created between thefirst leg 507 and the second leg 508, and between the third leg 509 andthe fourth leg 510.

FIG. 20A provides the method steps for manufacturing the shape-memorydevice 500. The process commences with step 62, wherein the shape-memorydevice 500 is sectioned off to create a first portion 501 and a secondportion 502. The portions may be created through the use of any of themethods disclosed in the previous embodiments, including the use of heattreatment jigs having platens with varied thermal conductioncapabilities, or platens formed from different materials. In thisspecific example, no shape setting is required for the first portion 501because the first portion 501 does not require any transformation. Thesecond portion 502 that includes the shape-memory is then formed into afirst shape 537, heat treated, and then deformed to the second shape538, thereby creating the shape-memory potential. Next, the firstportion 501 is permanently deformed to conform to site-specificanatomical conditions, as shown in step 64. One of ordinary skill in theart will recognize that any type of forming process may be utilized tocreate the permanent deformations.

After the shape-memory device 500 has been manufactured in this fashion,the shape-memory device 500 includes the first portion 501 that isanatomically adapted to the site specific conditions, and a secondportion 502 that retains the shape-memory potential. FIG. 20B provides amethod flowchart illustrating the method steps for utilizing theshape-memory device 500. As shown in step 66, a surgeon inserts theshape-memory device 500 into a desired location. In this particularexample, the desired location would be defined as a location wherein thefirst portion 501 adapts to the anatomical conditions, and the securingmembers of the shape-memory device 500 are in the proper securinglocations. One of ordinary skill in the art will recognize that the useof staples and the like, as implants, requires the securing of theimplant into bones through the use any suitable method, includingimpaction, or drilling securing holes. Once inserted into the properlocation, the second portion 502 is forced to shape change by deliveringactivation energy to the shape-memory device 500. Upon full activation,the shape-memory device 500 has transitioned to austenite, and the firstshape, step 68.

Alternatively, the shape memory device 500 may be formed as a compositeshape memory device, wherein the first portion 501 and the secondportion 502 are formed as separate components that are subsequentlysecured to each other. Illustratively, the first portion 501 may bemanufactured from a non shape-memory material, deformed to adapt toanatomical conditions, and attached to the second portion 502 that isformed from a shape-memory material, thereby providing all functions ofthe shape-memory device 500. One of ordinary skill in the art willrecognize that the non-shape-memory material utilized in this version ofthe shape-memory device 500 must be compatible with the human body ifthe shape-memory device 500 is to be utilized as an implant.

In a further alternative embodiment, a shape memory device 600 includesa multiple strand bridge 612 and legs disposed on the ends of the bridge612. In this specific example, the multiple strand bridge 612 includes afirst lateral member 610, a second lateral member 611, and first throughfourth strands 621-624 disposed between the first and second lateralmembers 610-611. First and second legs 614-615 are disposed on oppositeends of the first lateral member 610, and the third and fourth legs616-617 are disposed on opposite ends of the second lateral member 611.The legs 614-617 extends to a single side of the bridge 612, such thatthe legs 614-617 may be secured to adjacent structures, such as afractured bone, or adjacent bones requiring correction.

As shown in FIGS. 21A-21B, the first through fourth strands 621-624extend from the first lateral member 610 to the second lateral member611, and are disposed substantially symmetrical about a mid-plane 620.In this second alternative embodiment, each of the strands 621-624includes a different transition temperature, such that they activate ina certain order when the activation energy is applied. In this specificexample, the first strand 621 has the lowest activation temperature, thesecond strand 622 has the next highest transition temperature, the thirdstrand 623 has the ext highest transition temperature, and the fourthstrand 624 includes the highest transition temperature. Accordingly, afirst portion 601 includes the first strand 621, a second portion 602includes the second strand 622, a third portion 603 includes the thirdstrand 623, and a fourth portion 604 includes the fourth strand 624.

As described in previous embodiments, the shape memory devices formedfrom shape-memory materials comprise a first shape and a second shape.In this specific example, each of the first through fourth portions601-604 include a first and second shape, and move from the second shapeto an end use shape upon the application of activation energy. Aspreviously disclosed, an end use shape may be any shape moving from arespective second shape up to an including the first shape.

In operation, the shape memory device 600 functions in similar fashionto the shape memory devices of the previous embodiments, whereby theshape memory device 600 secures to adjacent bones, and then re-orientsthe adjacent bones. FIG. 21B provides a top view of the shape memorydevice 600 before activation. At this point, the first through fourthportions 601-604 are at a temperature below A_(s), and, accordingly, allstrands 621-624 are disposed in their respective second shapes 631, 633,635, and 637. As shown in FIG. 21C, the first strand 621 has reachedtemperature A_(F), and the first portion 601 has moved from the secondshape 631 to the first shape 630. In this particular example, the firststrand 621 contracts when moving from the second shape 631 to the firstshape 630. If heat continues to be applied, the second strand 622reaches temperature A_(F), as shown in FIG. 21D, and the second strand622 moves from the second shape 633 to the first shape 632. In thisparticular example, the second strand 622 contracts when moving from thesecond shape 633 to the first shape 632. At this point, the first andsecond strands 621-622 are in their respective first shapes 630 and 632,and the third and fourth strands 623-624 are in their respective secondshapes 635 and 637.

The continued application of heat energy to the shape memory device 600causes the third strand 623 to reach temperature A_(F), as shown in FIG.21E, and the third strand 623 moves from the second shape 635 to thefirst shape 634. In this specific example, the third strand 623contracts when moving from the second shape 635 to the first shape 634.At this point, the first, second, and third strands 621-623 are in theirrespective first shapes 630, 632, and 634, and the fourth strand 624 isin the second shape 637.

The continued application of heat energy to the shape memory device 600causes the fourth strand 624 to reach temperature A_(F), as shown inFIG. 21F, and the fourth strand 624 moves from the second shape 637 tothe first shape 636. In this particular example, the fourth strand 624contracts when moving from the second shape 637 to the first shape 636.At this point, the first through fourth strands 621-624 are in theirrespective first shapes 630, 632, 634, and 636.

While this particular example has been shown with first through fourthportions 601-604, one of ordinary skill in the art will recognize thatvirtually any number of strands may be utilized to accomplish variousmovements. One of ordinary skill in the art will further recognize thatthe order of transition may be adjusted by applying heat energy to thestrands individually, or by heat treating the shape-memory device 600 ina heat treatment jig as described in the previous embodiments to achievevaried transition temperatures in a single body. Alternatively, theshape memory device 600 may be formed from different materials asdescribed in the previous embodiments.

Although the present invention has been described in terms of theforegoing preferred embodiment, such description has been for exemplarypurposes only and, as will be apparent to those of ordinary skill in theart, many alternatives, equivalents, and variations of varying degreeswill fall within the scope of the present invention. That scope,accordingly, is not to be limited in any respect by the foregoingdetailed description; rather, it is defined only by the claims thatfollow.

1. A shape-memory device, comprising: (a) a first portion comprising afirst shape memory material, wherein the first portion has a firsttransition temperature; and (b) a second portion comprising a secondshape memory material, wherein (i) the second portion is adapted toconform to an anatomical location, (ii) the second shape memory materialhas a state transition temperature, wherein the state transitiontemperature is a temperature at which the second shape memory materialwould change from a martensitic state to an austenite state, (iii) thesecond shape memory material of the second portion is in the austenitestate, (iv) the state transition temperature is below the firsttransition temperature, and (v) the state transition temperature isbelow the temperature at which the shape-memory device is adapted toconform to the anatomical location and such that the second shape memorymaterial is operable to remain in the austenite state when conformed tothe anatomical location.
 2. The shape-memory device according to claim1, wherein the first portion is operable to transition from a firstshape to an end use shape upon the application of a first activationenergy. 3-27. (canceled)
 28. A shape-memory device, comprising: (a) afirst portion comprising a first shape memory material having a firsttransition temperature; (b) a second portion having no transitiontemperature, wherein (i) the second portion is adapted to conform to ananatomical location, and (ii) the first portion is operable to beactivated to move from a first shape to an end use shape upon theapplication of activation energy.
 29. The shape-memory device accordingto claim 28, wherein the second portion comprises a second shape memorymaterial in a totally martensite state.
 30. The shape-memory deviceaccording to claim 28, wherein the second portion comprises a secondshape memory material in a totally austenite state.
 31. The shape-memorydevice according to claim 28, wherein the first portion and the secondportion comprises different materials connected together in a compositeshape-memory device.
 32. The shape-memory device according to claim 31,wherein the second portion comprises a non-shape-memory material. 33-52.(canceled)
 53. The shape-memory device according to claim 28, the firstportion is operable to be activated to move from a first shape to an enduse shape upon the application of activation energy to secure theshape-memory device in place at the anatomical location.
 54. Theshape-memory device according to claim 28, wherein the second portioncomprises a second shape memory material that is in a state that isneither martensite nor austenite.
 55. The shape-memory device accordingto claim 28, wherein the shape-memory device is an implant.
 56. Theshape-memory device according to claim 28, wherein the shape-memorydevice is operable to connect bones.
 57. The shape-memory device ofclaim 1, wherein the first shape memory material and the second shapememory material are different types of shape memory materials.
 58. Theshape-memory device of claim 1, wherein the first shape memory materialand the second shape memory material are the same type of shape memorymaterial.
 59. The shape-memory device of claim 58, wherein the same typeof shape memory material is nitinol.
 60. The shape-memory deviceaccording to claim 1, wherein the shape-memory device is an implant. 61.The shape-memory device according to claim 1, wherein the shape-memorydevice is operable to connect bones.
 62. A shape-memory device,comprising: (a) a first portion comprising a first shape memorymaterial, wherein the first portion has a first transition temperature;and (b) a second portion comprising a second shape memory material,wherein (i) the second portion is adapted to conform to an anatomicallocation, (ii) the second shape memory material has a state transitiontemperature, wherein the state transition temperature is a temperatureat which the second shape memory material would change from an austenitestate to a martensite state, (iii) the second shape memory material ofthe second portion is in the martensite state, (iv) the state transitiontemperature is above the first transition temperature, and (v) the statetransition temperature is above the temperature at which theshape-memory device is adapted to conform to the anatomical location andsuch that the second shape memory material is operable to remain in themartensite state when conformed to the anatomical location.
 63. Theshape-memory device according to claim 62, wherein the first portion isoperable to transition from a first shape to an end use shape upon theapplication of a first activation energy.
 64. The shape-memory device ofclaim 62, wherein the first shape memory material and the second shapememory material are different types of shape memory materials.
 65. Theshape-memory device of claim 62, wherein the first shape memory materialand the second shape memory material are the same type of shape memorymaterial.
 66. The shape-memory device of claim 65, wherein the same typeof shape memory material is nitinol.
 67. The shape-memory deviceaccording to claim 62, wherein the shape-memory device is an implant.68. The shape-memory device according to claim 62, wherein theshape-memory device is operable to connect bones.
 69. A shape-memorydevice, comprising: (a) a first portion comprising a first shape memorymaterial in a first shape; and (b) a second portion comprising a secondshape memory material, wherein (i) the second portion is operable topermanently deform to conform to an anatomical location while the firstportion remains in the first shape, (ii) the first portion is operableto transition from the first shape to an end use shape upon theapplication of a first activation energy while the second portionremains conformed to the anatomical location.
 70. The shape-memorydevice of claim 69, wherein the first shape memory material and thesecond shape memory material are the same type of shape memory material.